SF- 1.1% sodium fluoride gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Tillgänglig från:

Cypress Pharmaceutical, Inc.

INN (International namn):

SODIUM FLUORIDE

Sammansättning:

FLUORIDE ION 11 mg in 1 g

Administreringssätt:

DENTAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

A dental caries preventive, for once daily self-applied topical use.  It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 SF 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray.  This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional.  May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.) Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician. The use of SF 1.1% Brush-On Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2,3,4 .  Safety and effectiveness in pediatric patients

Produktsammanfattning:

2 oz. (56g) net wt. plastic tube. Flavor: Fresh Mint NDC 60258-151-01

Bemyndigande status:

unapproved drug other

Produktens egenskaper

SF - 1.1% SODIUM FLUORIDE GEL
CYPRESS PHARMACEUTICAL, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SF 1.1% GEL 1.1% SODIUM FLUORIDE - BRUSH-ON GEL
DESCRIPTION
Self-topical neutral fluoride gel containing 1.1% (w/v) sodium
fluoride for use as a dental caries
preventive in pediatric patients and adults. This prescription product
is not a dentifrice.
ACTIVE INGREDIENT: Sodium Fluoride, USP 1.1% (w/v).
INACTIVE INGREDIENTS
Purified Water, Sorbitol, Hydroxyethylcellulose, Flavor, Poloxamer
407, Sodium Saccharin,
Methylparaben, Propylparaben, FD&C Blue No. 1.
CLINICAL PHARMACOLOGY
Frequent topical applications to the teeth with preparations having a
relatively high fluoride content
increase tooth resistance to acid dissolution and enhance penetration
of the fluoride ion into tooth
enamel.
INDICATIONS AND USAGE
A dental caries preventive, for once daily self-applied topical use.
It is well established that 1.1%
sodium fluoride is safe and extraordinarily effective as a caries
preventive when applied frequently
with mouthpiece applicators.
SF 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a
toothbrush as well as a mouthpiece tray. This prescription dental gel
should be used once daily
following use of a regular toothpaste unless otherwise instructed by
your dental professional. May be
used whether or not drinking water is fluoridated since topical
fluoride cannot produce fluorosis. (See
WARNINGS for exception.)
CONTRAINDICATIONS
Do not use in pediatric patients under age 6 years unless recommended
by a dentist or physician.
WARNINGS
Prolonged daily ingestion may result in various degrees of dental
fluorosis in pediatric patients under 6
years, especially if the water fluoridation exceeds 0.6 ppm, since
younger pediatric patients frequently
cannot perform the brushing process without significant swallowing.
Use in pediatric patients under
age 6 years requi